MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, FILL TUBE; ARCTIC SUN - FILL TUBE

Catalog Number 718-00

Device Problem Partial Blockage (1065)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/10/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported that during routine service, the arctic sun device showed fault 41(low internal flow with no flow rate showing).The device took several attempts to fill also before functionality test was carried out.Per investigator notification received on 10aug2023, it was reported that the fill tube filter was blocked.

Manufacturer Narrative

The reported issue was confirmed.The root cause of the reported issue could not be determined.A potential root cause of the reported issue is inadequate maintenance of the device.However, this cannot be confirmed.The device was evaluated upon receipt.It was confirmed that fill tube filter was blocked.Fill tube was replaced.A dhr review is not required as the serial number is unknown.The instructions for use were found adequate and state the following: "cleaning and maintenance routine cleaning and preventive maintenance should be performed on the arctic sun¿ temperature management system control module every 6 months at a minimum.This consists of cleaning the external surfaces, accessories and chiller condenser, inspecting the device, and replenishing the internal cleaning solution that suppresses microorganism growth in the water reservoir and hydraulic circuit.See the arctic sun¿ temperature management system service manual for additional information." h11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported that during routine service, the arctic sun device showed fault 41(low internal flow with no flow rate showing).The device took several attempts to fill also before functionality test was carried out.Per investigator notification received on 10aug2023, it was reported that the fill tube filter was blocked.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, FILL TUBE
• Type of Device: ARCTIC SUN - FILL TUBE
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer (Section G): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 17611544
• MDR Text Key: 321832986
• Report Number: 1018233-2023-06280
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741080197
• UDI-Public: 00801741080197
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K161602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 718-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2023
• Initial Date FDA Received: 08/24/2023
• Supplement Dates Manufacturer Received: 12/14/2023
• Supplement Dates FDA Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other